[Ip-health] Wall Street Journal: Gates Won't Fund AIDS Researchers Unless They Pool Data

[Thiru Balasubramaniam]

Gates Won't Fund
AIDS Researchers
Unless They Pool Data
By MARILYN CHASE
July 20, 2006; Page B1

Frustrated that over two decades of research have failed to produce an
AIDS vaccine, Microsoft Corp. Chairman Bill Gates is tying his
foundation's latest, biggest AIDS-vaccine grants to a radical concept:
Those who get the money must first agree to share the results of their
work in short order.
[Bill Gates]

Even as AIDS researchers around the world strive toward a common goal,
they do so largely independent of one another due to a mix of
commercial interests, bureaucratic jostling and personal rivalries.
Like most biomedical research, results of AIDS-related studies are
often carried out in secrecy, with successes and failures closely held
until they are published in scientific journals months later.

So far, attempts to come up with a vaccine that produces protective
antibodies to block infection by the wily and shape-shifting AIDS virus
have been a "miserable failure," says Nick Hellmann, interim director
of HIV projects at the Bill & Melinda Gates Foundation.

Now, Mr. Gates's family foundation is putting $287 million new,
five-year grants behind the notion that pooling results can surmount
the massive technical hurdles that have hindered individual,
sometimes-competing efforts.

"The whole field recognizes that in order to meet this humongous
challenge, we have to change the way we work," Dr. Hellmann says.
"There have to be better networks and collaborations. [So] we require
all grantees to collaborate across a spectrum of grants."

Through such data sharing, Dr. Hellmann says, rival teams can build on
successes, avoid pitfalls and eliminate redundancy. Even so, he says
that a vaccine is "at least 10 years away."
SHARE AND SHARE ALIKE

Details of AIDS vaccine grants from Gates Foundation
=95 Awards to 165 investigators from 19 countries.

=95 Divides grants into discovery and evaluation.

=95 Standardizes vaccine testing.

=95 Requires sharing of data and comparing of results.

Source: Gates Foundation

The new grants were awarded yesterday to 165 researchers from 19
countries. They were selected to tackle unsolved challenges targeted by
the Global HIV Vaccine Enterprise, a research alliance that declared in
2003 that fragmented vaccine experiments lack the scale to halt the
AIDS pandemic now affecting nearly 40 million people world-wide.

"Traditional ways...have largely failed," says Giuseppe Pantaleo, chief
of immunology at the Centre Hospitalier Universitaire Vaudois in
Lausanne, Switzerland. Dr. Pantaleo received a $15.3 million Gates
grant to create improved AIDS vaccines piggybacked on pox viruses akin
to the smallpox vaccine.

There's no guarantee these particular grants, or the Gates foundation's
efforts in general, will lead to a working vaccine. But since
fragmented vaccine efforts have yet to protect a single human from the
pandemic that rages out of control in many regions, some supporters
argue it's time for a new approach. Grant recipients and outside
observers were unsure whether data-sharing requirements of the grants
could pose potential legal or patent conflicts with Mr. Gates's vow to
respect intellectual property. Foundation officials said this week
researchers would still be free to commercialize their discoveries, but
they must develop access plans for people in the developing world.

The foundation declined to make its attorney available to address these
concerns.

There are four major goals to be funded by the grants: vaccines that
spark neutralizing antibodies to block initial infection by HIV;
vaccines that make stronger T-cell response to kill infected cells;
creation of standard criteria to measure success or failure; and a new,
secure Web site for sharing all the data in real time.

"Whether in academics or industry, scientists want to protect
intellectual property. ... With the alliance, the shift is to say: 'No,
the large enterprise is more important than the position I keep by
holding my data close,'" says Steve Self, a biostatistician at the Fred
Hutchinson Cancer Research Center in Seattle, which is lead
investigator of a $30.1 million grant to create new adjuvants,
ingredients that boost a vaccine's power. Dr. Self got a $10 million
grant to create a secure central data repository to be named Atlas.

Enforced data sharing, Dr. Self predicted, "increases the pace of
discovery enormously rather than waiting for the process of writing
formal journal articles, waiting for them to be published, and
[confirmed] by other labs." As efforts funded by the Gates grants get
under way, other funders must not be lulled into complacency, warns
Mitchell Warren, executive director of the New York-based AIDS Vaccine
Advocacy Coalition, a nonprofit community group. Activists recently
have voiced concerns that the National Institutes of Health budget is
flat in real terms.
[Gatesjump]

Mr. Warren estimates that research efforts need more than $1 billion a
year, and that the Gates grants, to be paid out over five years, will
boost total annual investment to just over $800 million.

Some big names from industry and academia chose not to seek the Gates
grants because they already had other funding, conflicting commercial
commitments, or uncertainty about the program's impact on existing
partnerships. "We had linkages that caused us to think we weren't ready
to go in," says AIDS researcher Robert Gallo, co-discoverer of the AIDS
virus and director of the Institute for Human Virology at the
University of Maryland in Baltimore.

Dr. Gallo is funded by the National Institutes of Health, the
pharmaceutical industry and other federal programs. In 2005, he
co-founded Profectus Biosciences Inc., which licensed intellectual
property of his lab and plans to commercialize it.

Collaboration doesn't replace the spur of competition, Dr. Gallo says.
His race with Luc Montagnier of the Pasteur Institute in Paris to
discover the AIDS virus led to competing claims and a lawsuit by the
French for credit and a share of patent royalties from the HIV blood
test.

But Dr. Gallo says he approves the notion of a megaproject for AIDS
vaccines. "I tried to push for a vaccine crash program back in 1988,"
he says. "It used to be said the science isn't ready. But it'll be
readier than if we don't do it." He added that he may apply for future
Gates funding.

Another of industry's most productive AIDS researchers absented himself
from the Gates grant program. "We're not participating," says Emilio
Emini, vice president of vaccine research and development at Wyeth
Pharmaceuticals. He adds that Wyeth's proprietary vaccine discovery
program is already sufficiently funded and governed by existing grants
and contracts with NIH. He says the company will continue operating its
own independent research program.

Write to Marilyn Chase at marilyn.chase@wsj.com1